ASME NQA-1 and Interface Control

Greetings Cove Folks!!

Alas, it has been a while since I was here last. I managed to find myself moved out of the Quality field for a couple of years as my company was looking to open a new branch and I was slated to lead the operations there. Unfortunately, the recent economic melt-down has put those plans on indefinte hold and with the departure of my replacement in the Quality Department, I was offered the opportunity to take on my old role AND keep my new responsibilities in marketing. Wooo Hooo!! An offer TOO good to pass-up. *Can anyone else smell the sarcasm??* But I shouldn't complain... I have a job, so it is all good.

So... what brings me here, you ask?? Well... as part of our efforts to expand our markets, we are entertaining the possibility of obtaining our N-Stamp for our hose assemblies. It has fallen to me to conduct a gap analysis between the current state of our QMS and the various requirments of NQA-1, NCA 3800, 10CFR50 Appendix B, etc., etc., etc.

I am running into a bit of confusion with respect to Interface Control... (NQA-1, Requirement 1, Section 300) -- specifically the part that talks about "internal interfaces between organizational units... shall be documented". While I understand external interface control... does anyone know what internal interface control means? Are they referring to the interactions between the various departments (or process owners) within the organization? Doesn't a Process Map demonstrate these and is that sufficient "documentation"?

Any enlightmentment would be extremely appreciated!!

Thanks!!

Michael

Re: NQA-1 and Interface Control

Michael T said:

Are they referring to the interactions between the various departments (or process owners) within the organization? Doesn't a Process Map demonstrate these and is that sufficient "documentation"?

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It sounds like your interpretation is correct. A process map would demonstrate that it should be done but how do you document that it was done in accordance with the map (procedure)? What evidence (record) would be produced?

Re: NQA-1 and Interface Control

Thanks BadgerMan...

Your question was the next in my line of thought... how do we provide evidence that the various departments communicate?

Every morning we have a Production Meeting between Customer Service and the various manufacturing department supervisors to discuss any issues that effect schedules and quoting lead-times, review back-orders, etc. There are no records from these meetings except the occasional e-mail to Customer Service and the Management Team that we're short on X product or Y machine is down for maintenance. If there are no issues, no e-mail goes out.

Does anyone think that this would be sufficient evidence or do we need to put together some kind of meeting minutes? It seems kind of silly to me... generate some unnecessary document just for this...

Thanks!!

Mike

Re: NQA-1 and Interface Control

We've been audited several times to the NQA-1 standard, and we've never really had to specifically show minutes for (what we would call) a scheduling meeting. We do have meetings with minutes, and others without. They've always accepted us as we are. Truthfully, I've never really seen any difference in the audits from a good ISO 9001 audit. BTW, I just got a request from a customer to perform one not 5 minutes ago.

Re: NQA-1 and Interface Control

Thanks SM!!

NQA-1 didn't seem that much different from ISO except for some enhanced requirements with respect to the Design Control function.

Have fun with your audit!!

Cheers!!

Michael

Re: NQA-1 and Interface Control

Michael T said:

Thanks SM!!

NQA-1 didn't seem that much different from ISO except for some enhanced requirements with respect to the Design Control function.

Have fun with your audit!!

Cheers!!

Michael

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and....considering that we don't design anything, it works well for us...we'll see how this one goes. This time, I am not sure that we will be getting contracted Nu-Pic auditors, it sounds more like the customer's people, but not sure. Sometimes, it is worse if you don't get someone actually sanctioned by the NRC and/or powers that be, because they can be as unsure of what to look for as we are what to provide. The QA Manager that I've been talking to sounds like a really decent guy.

Re: NQA-1 and Interface Control

Oh, you are LUCKY!! No design control. Sweet. We have a hard time with that one because we design our products for the market not for a specific customer. And, when the president gets it in his head that he wants to design something new... he just goes for it... design control... we don't need no stinkin' design control... (He's an engineer and an entrepreneur... a dangerous combination).

Glad the QA guy sounds decent... I've had both. One of the last audits I was on before I got moved out of QA was by TUV for the Pressure Equipment Directive (PED). OMG!! The auditor kept hitting me with these little issues and when I asked him how I was supposed to know this stuff when the PED is not specific, he said, (German accent on) "You have to get beat up in an audit." (German accent off) Wrong answer!!!

He comes back in a couple of months for the annual audit... I just can't wait.

Cheers!!!!

Michael

Re: NQA-1 and Interface Control

We lucked out with the PED too, our registrar has an office in Dublin. Both audits at once.

Re: NQA-1 and Interface Control

We're about 95% of the way to switch over our ISO audit to TUV and combining the ISO & PED audits. The TUV auditor, while a real ball buster, sure knows his stuff and really adds value. Right now we're trying to figure out if we want to pursue pressure accessories for our Expansion Joints (EJ) or stick with component registration for the flexible metal hose assemblies. We lost our lead EJ engineer, so that kinda put a crimp in the fast-track we had going.

Re: NQA-1 and Interface Control

Hey SteelMaiden... if I may pose one more question... And anyone else who might have some insight...

Requirement 12 - Control of Measuring and Test Equipment.

The requirement calls out TOOLS as well was gages, instruments... etc., etc., etc.

I'm a little unclear on what might qualify as a tool... (besides me for taking on this task )

For instance... a linear speed indicator or the amperage on a welder... would that be considered a tool? During set-up, I can set the speed to 8 and the amperage to 80 and get the same weld as if I set the speed to 4 and the amperage to 40. (Numbers are PURELY hypothetical... just for illustration). A burst test of the weld at the particular setting is conducted prior to production to ensure the integrity of the weld. And, all of our set-up sheets are starting points, it is up to the operator to "dial in" the machine to obtain the proper weld.

Any thoughts?

Thanks!!!

Michael

ps... Everyone have a great weekend!!